Quality Assurance TechnicianReports To: Designated Person (DP) / Quality Assurance ManagerCompensation: starting at $32/hour Shift Options: 2nd Shift (4:00 pm - 12:00 am) Position SummaryThe Quality Assurance Technician supports the pharmacy’s Quality Management System (QMS) and compliance programs by assisting with quality assurance activities, documentation review, environmental monitoring coordination, investigations, and regulatory readiness initiatives.
This role helps ensure sterile and non-sterile compounding operations are performed in accordance with internal policies and procedures, current USP standards, state and federal regulations, and applicable quality and patient safety requirements.
The Quality Assurance Technician works collaboratively with pharmacists, pharmacy technicians, production personnel, and leadership to support continuous quality improvement and maintain a culture of compliance and patient safety. Quality Assurance & Compliance Support- Assist with implementation, maintenance, and continuous improvement of the pharmacy Quality Management System (QMS)
- Review batch records, compounding documentation, cleaning logs, and related records for completeness, accuracy, and compliance
- Support deviation, nonconformance, corrective and preventive action (CAPA), and change control processes
- Maintain quality records, logs, and compliance documentation in accordance with document control procedures
- Escalate quality concerns, documentation discrepancies, and compliance issues appropriately
Environmental Monitoring & Facility Compliance- Assist with viable air, non-viable particle, and surface sampling activities
- Maintain environmental monitoring records including temperature, humidity, and pressure differential documentation
- Support cleanroom certification scheduling and tracking
- Assist with monitoring maintenance and calibration requirements for equipment and controlled environments
- Help ensure compliance with USP <797>, USP <800>, and applicable regulatory standards
Product & Process Quality Monitoring- Assist with quarantine, identification, and segregation of nonconforming materials or compounded preparations
- Coordinate or support sterility, endotoxin, potency, and outsourced laboratory testing activities
- Monitor and trend quality metrics and environmental monitoring results
- Support investigations related to product complaints, deviations, out-of-specification results, or quality events
- Participate in root cause analysis and corrective action follow-up activities
Documentation & Training Support- Maintain controlled documents including SOPs, forms, logs, and quality records
- Assist with employee training documentation and competency tracking
- Support staff education initiatives related to quality assurance, compliance, and aseptic practices
- Ensure documentation is completed accurately, legibly, and in a timely manner
Audit & Inspection Readiness- Assist with preparation for regulatory inspections, accreditation surveys, and internal audits
- Gather records and supporting documentation during inspections and audit activities
- Participate in implementation and follow-up of corrective actions resulting from inspections or audits
- Support ongoing inspection readiness efforts throughout the pharmacy
QualificationsEducation- High school diploma or equivalent required
- Active pharmacy technician registration/licensure preferred, where applicable
- National pharmacy technician certification preferred
Experience- Preferred experience in sterile or non-sterile compounding pharmacy
- Quality assurance or quality control programs
- USP <795>, USP <797>, and/or USP <800> environments
- Regulated healthcare, pharmaceutical, or laboratory settings
Knowledge, Skills, and Abilities- Strong attention to detail and documentation accuracy
- Understanding of aseptic technique and cleanroom practices preferred
- Strong organizational and time management skills
- Ability to communicate effectively with cross-functional teams
- Ability to identify, document, and escalate quality concerns appropriately
- Proficiency with electronic documentation systems and Microsoft Office applications preferred
- Ability to maintain confidentiality and professionalism in a regulated healthcare environment
Physical Requirements- Ability to stand and walk for extended periods
- Ability to lift and transport supplies and equipment as needed
- Ability to work in cleanroom environments while wearing required PPE
- Ability to perform duties requiring repetitive hand movements and visual inspection tasks
Performance Expectations- Maintain accurate, timely, and compliant documentation
- Adhere to all pharmacy policies, procedures, and regulatory requirements
- Support continuous quality improvement initiatives
- Promote a culture of compliance, accountability, and patient safety
- Demonstrate professionalism, teamwork, and attention to detail in all responsibilities
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